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Xamiol 15g gel




The instruction for medical use of Xamiol® medicine the Trade name of Xamiol® the International unlicensed name Is not present the Dosage form Gel, 15 g Structure of 1 g of gel contain active agents: betamethasone Dipropionas of 0.643 mg (it is equivalent to betamethasone of 0.5 mg), a kaltsipotriola monohydrate of 0.052 mg (it is equivalent to a kaltsipotriol of 0.05 mg) excipients: paraffin liquid, polyoxypropylene-11-stearyl ether, the castor oil hydrogenated, butyl hydroxytoluene (E321) *, all-rac--tocopherol ** * contains as a part of polyoxypropylene-11 of stearyl ether as antioxidant in number of 0.1% ** the Description Almost transparent, from colourless till almost white color lipophilic gel contains as a part of liquid paraffin as antioxidant in number of about 10 ppm. On a surface the thin fat film can be observed. Pharmacotherapeutic group Drugs for treatment of psoriasis. Drugs for treatment of psoriasis for topical administration. Other drugs for treatment of psoriasis for topical administration. Kaltsipotriol, combinations. The ATX D05AX52 code the Pharmacological Pharmacokinetics At properties external use of Xamiola® absorption of a kaltsipotriol and betamethasone through the uninjured skin makes less than 1%. When putting drug on psoriasis plaques and under occlusive bandages the absorption of a topical glucocorticosteroid (GKS) increases. As in skin the depot of drug is created, its elimination comes from skin within several days. The insignificant quantity of the soaked-up kaltsipotriol is exposed to biotransformation in a liver with formation of low-active metabolites which it is inactivated within 24 hours, are removed by kidneys and through intestines. Betamethasone is metabolized in a liver and in kidneys with formation of glucuronides and sulfoethers, excretion is carried out through intestines and kidneys. A pharmacodynamics of Xamiol® the combined drug for treatment of psoriasis. Kaltsipotriol – a synthetic analog of an active metabolite of vitamin D. Causes slowing down of proliferation of keratinotsit and accelerates their morphological differentiation. Betamethasone – a glucocorticosteroid for external use, renders local anti-inflammatory, antipruritic, vasopressor and immunosuppressive action, however, exact mechanisms of anti-inflammatory effect of topical steroids are up to the end not clear. Use of occlusive bandages enhances effect of topical GKS as at the same time their penetration through skin increases. Indications – psoriasis of a hairy part of the head – vulgar blyashechny psoriasis (easy and moderate severity) the Route of administration and doses Gel should be caused with a thin layer on affected areas of a body and a hairy part of the head of 1 times a day. The recommended duration of a course of treatment of psoriasis of a hairy part of the head 4 weeks and other affected areas of a body of 8 weeks. In need of Xamiol® it is possible to apply repeatedly under observation of the doctor. Maximum day dose no more than 15 g. For treatment of psoriasis of a hairy part of the head it is possible to apply gel from 1 g to 4 g a day (4 g correspond to one teaspoon). The area of putting drug should not exceed 30% of a body surface. Before the use it is necessary to stir up a bottle and to apply gel on the struck area. Gel has to remain on an affected area at night or during the day, it is not recommended to wash away for achievement of optimum effect. Side effects are listed below the observed side reactions with a frequency of their occurrence: very often (³ 1/10), it is frequent (from ³ 1/100 to & lt, 1/10), infrequently (from ³ 1/1000 to & lt, 1/100), is rare (from ³ 1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000). Often – an itching Infrequently – skin infections (including bacterial, fungal and viral skin infections), folliculites – irritation of eyes – exacerbation of psoriasis, burning sensation of skin, irritation of skin, dermatitis, an erythema, an acne, xeroderma, rash (erythematic and pustulyarny) – pain in sites of application (including burning in sites of application of gel) is rare – hypersensitivity – skin striya, peeling of skin – converse effect Kaltsipotriol belong reactions in the site of application of drug To undesirable medicinal reactions, an itching, skin reactions, burning sensation and tinglings, xeroderma, an erythema, rash, dermatitis, eczema, strengthening of psoriasis, a photosensitization and the reactions of hypersensitivity including very exceptional cases of a Quincke’s disease and face edema. Betamethasone (in the form of Dipropionas) Local reactions can arise after local use, especially after prolonged use. The atrophy of skin, a teleangiectasia, a striya, a folliculitis, a hypertrichosis, perioral dermatitis, allergic contact dermatitis, a depigmentation and colloidal dystrophy of skin belong to them. At treatment of psoriasis the risk of developing generalized pustulous psoriasis exists topical kortikosterioda. System reactions – the hypercalcemia or a hypercalcuria connected with use of a kaltsipotriol – suppression of function of bark of adrenal glands, a cataract, infections, influence on metabolic control of diabetes, increase in intraocular pressure (especially after prolonged use). System reactions rare, but sometimes heavy, most often happen at prolonged use, on big surfaces and when using occlusive bandages. Contraindications – hypersensitivity to any of drug components – erythrodermic, exfoliative and pustulous psoriasis – the diseases which are followed by calcium metabolism disturbance – virus (including herpes or chicken pox), fungal, bacterial and parasitic infections of skin, a rozatse, pink eels, vulgar eels, perioral dermatitis, skin manifestations of tuberculosis, an atrophy of skin, a skin ulcer, the increased fragility of vessels of skin, an ichthyosis Medicinal interactions are not known Special instructions. It is not recommended to apply drug to skin of face, genitals and to eyes. After putting gel it is necessary to wash up hands carefully. Risk of development of a hypercalcemia at observance of the recommended mode of dosing is minimum. However, at use of Xamiola® in the doses exceeding the recommended maximum daily dose (15 g) the development of the hypercalcemia passing at drug withdrawal is possible. Ксамиол® contains strong GKS therefore it is not recommended to carry out the accompanying treatment by other GKS. At prolonged use the risk of development of side reactions increases. In case of the side effects connected with long use of GKS, treatment needs to be interrupted. It is recommended to avoid use of drug on the extensive sites of skin making more than 30% of a body surface and also under an occlusive bandage, to put in skin folds as it increases the probability of system absorption of GKS and development of system side reactions. By-effects, such as suppression gipotalamo – a hypophysial and adrenal system with development of reversible secondary adrenal insufficiency or exacerbation of diabetes, GKS connected with system appointment, can be observed also at use of topical GKS, owing to system absorption. At a psoriasis complication consecutive infection, it is necessary to carry out antibacterial therapy, and at aggravation of an infection to cancel Xamiol®. During treatment of Xamiolom® the doctors have to recommend to patients to limit or avoid excessive impact of natural or artificial sunlight. Kaltsipotriol for topical administration has to be used with Ural federal district, only if the doctor and the patient consider that the potential advantage outweighs potential risks. Ксамиол® gel contains the castor oil hydrogenated which can cause local skin reactions. Use for children Experience of use of Xamiola® for children is younger than 18 years is absent. Pregnancy and a lactation Safety of use of Xamiola® at pregnancy is not established therefore drug can be used only when, according to the doctor, the potential advantage for mother exceeds potential risk for a fruit. There are no data on penetration of a kaltsipotriol into breast milk. Betamethasone gets into breast milk, however the risk of an adverse effect on the child is improbable at use of drug in therapeutic doses. It is necessary to be careful at use of Xamiola® during feeding by a breast. It is necessary to instruct the patient that it is not recommended to apply gel on a breast. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms the Overdose Symptoms does not influence: increase in content of calcium in blood (it is shown in the form of a polyuria, a constipation, muscle weakness, confusion of consciousness and a coma), suppression of function of a hypophysial and adrenal system with development of reversible secondary adrenal insufficiency. Treatment: to cancel drug and to carry out symptomatic therapy. In cases of chronic toxicity GKS should be cancelled gradually. The form of release and packing On 15 g of gel place in the bottle from polypropylene equipped with a nozzle and the screw-on cover. On 1 bottle together with the instruction for medical use in the state Russian languages place in a cardboard pack. Storage conditions At a temperature not above 25 °C, in the place protected from light. Not to store in the fridge. To store out of children’s reach! A period of storage 2 years After opening – 3 months not to use drug after expiry date Prescription status According to the prescription LEO Producer of Pharm of A/S, Ballerup, Denmark the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Takeda Osteuropa Holding GmbH (Austria) in Kazakhstan Almaty, Shashkin St. 44
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